The Central Licensing Authority (CLA) and Central Drugs Standard Control Organisation (CDSCO) are the regulatory bodies that supervise all medical device permissions to conduct clinical investigations. The timeline for receiving the permission from them to conduct a clinical investigation of an investigational medical device (MD) is around 1 to 2 months.
The manufacturers and importers who wish to carry out a clinical investigation of an investigational medical device should obtain permission from the CLA, which can be done through an online application process.
The manufacturers and importers can apply for this service through the following process:
Any manufacturer or importer who wants to do a clinical investigation of an investigational Medical Device may apply to the CLA through this service.
|Step 1: The application for grant of permission to conduct a clinical investigation of an investigational Medical Device can be made in Form MD-22|
|Step 2: The application should address the Central Licensing Authority of India and the Central Drugs Standard and Control Organisation.|
|Step 3: The application should be submitted with the required documents and the application fees on the SUGAM portal.|
The license will not expire once the permission has been obtained to conduct the clinical investigations for the medical device unless there is a suspension or cancellation from the authorities.
Timeline to get permission to conduct Clinical Investigation of Medical Device is 1-2 months
The following three essential tips will benefit during the application process:
While conducting the clinical investigation of the investigational medical devices, the Ethics Committee approval letter is necessary.
During the application process, the biocompatibility test reports are necessary to carry out the clinical investigation.
The Clinical Investigation Plan is also required for the application. Problems can be faced during the application process. To avoid them, applicants can ensure the following:
First, the clinical investigation plan must be approved by the registered Ethics Committee and only then the clinical investigation should be initiated.
The enrolment of the first participant within 1 year of permission is required before initiating the clinical investigation. Therefore, it should be done within one year from the date of grant of permission. Failing recruitment within 1 year of permission, prior approval from the CLA will be required again to initiate the clinical investigation.
The applicant needs to provide complete medical management or compensation according to the MDR, 2017, in case there is any injury or death of a subject during the clinical investigation.
CliniExperts provides certain advice to their clients -
Applicant should possess a letter of approval from the Ethics Committee as an essential document before applying for permission to conduct clinical investigations of an investigational Medical Device.
The clinical investigations study must be performed in a CDSCO-approved laboratory.
The clinical investigation should be registered with the Clinical Trial Registry of India before enrolling the first participant in Clinical Investigation
No. The clinical investigation or evaluation will not be waived off for devices that are already on the market and notified later. The medical devices will be evaluated on a case-by-case basis, which will be based on their intended use and the data available to verify their safety and efficacy. The SEC may also be consulted on this issue.
No. According to the Rules 36 sub-rule (4), any medical device that is imported from other countries than those listed in Rules 36 sub-rule (3), the license for Class C and D medical devices will be granted after the complete safety and effectiveness is well established through a clinical investigation in India which is specified under the provision of Chapter VII of these rules. In the case of Class A and B devices, the license will be granted only after its safety and performance check get established through safety and performance data. It can also be done through clinical investigation, or a free sale certificate from the country of origin is furnished.
No. If the regulatory authorities approve the investigational Medical Devices in the United Kingdom, the United States of America, Australia, Canada, or Japan, the clinical investigation results in India might not be required. It is essential that these approved medical devices should have been marketed for at least two years in said country and that the Central Licensing Authority needs to be satisfied with the data on the safety of the device, performance and pharmacovigilance.
Yes. Every applicant must obtain a separate investigational device approval for each new Medical Device.
Yes, it is necessary to initiate the clinical investigation by enrolling the first participant within one year from the date of grant of permission. Otherwise, the permission from the Central Licensing Authority gets cancelled and required to apply again to initiate a clinical investigation.